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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP Back to Search Results
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 10/17/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Date of implant: 2015.Concomitant medical products: part #unknown / unknown neck / lot # unknown.Part #unknown / unknown head/ lot # unknown.Part # unknown/ unknown shell/ lot # unknown.Part # unknown/ unknown stem/ lot #unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01573.
 
Event Description
It was reported patient underwent hip surgery approximately 5 years ago and was revised in the same year due to instability subsequently patient underwent closed reduction and additional revision due to instability and dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
UNKNOWN LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9948726
MDR Text Key187222164
Report Number0001825034-2020-01572
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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